Exploring the Efficacy of the Effortful Swallow Maneuver for Improving Swallowing in People With PD
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alberta
About this trial
The goal of this clinical trial is to learn whether a 4-week effortful swallow exercise program helps adults with Parkinson disease who have swallowing problems. The effortful swallow is a swallowing exercise where a person swallows with extra effort.
Researchers will compare adults who start the exercise program right away with adults who start the program after a 4-week waiting period. All participants who remain eligible will have the opportunity to receive the exercise program.
Participants will have swallowing assessments, including video X-ray swallowing tests called videofluoroscopy. They will also complete questionnaires and take part in a remotely supervised swallowing exercise program with a speech-language pathologist. Participants who remain eligible and take part in the exercise program will use a tongue pressure device during practice. The main study period lasts about 10 weeks. Participants will also complete brief follow-up questionnaires at 6 months and 12 months.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older
Neurologist-confirmed diagnosis of Parkinson disease
Self-report of one or more swallowing symptoms, such as difficulty managing secretions, coughing during meals, choking on food, or respiratory infection other than COVID-19 in the past 6 months
Baseline videofluoroscopic swallowing assessment showing prolonged time to laryngeal vestibule closure and/or poor pharyngeal area at maximum constriction on regular-effort swallows with thin or mildly thick liquid stimuli, relative to healthy reference values
Disqualifiers
History of head and neck cancer
History of radical neck dissection, anterior cervical spine surgery, or neck/oropharyngeal surgery, except tonsillectomy or adenoidectomy
History of any neurological disease other than Parkinson disease
Cognitive or receptive communication difficulties that preclude the ability to follow English-language study instructions
Trial design
Design model
Parallel
Treatments tested in this trial
Effortful swallow
BehavioralA 4-week remotely supervised swallowing exercise program delivered by a speech-language pathologist. Participants will practise effortful swallows at home using saliva and mildly thick liquids, according to study instructions. Participants will use a tongue pressure device during practice to support measurement and feedback. Participants may also complete home practice logs.
Treatment groups
74 Participants
are divided into 2 treatment groupsGroup A: Immediate InterventionExperimental treatment 1 intervention
Group B: Delayed InterventionOther 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of Participants With Improved Swallowing Function at Week 5
Improved swallowing function will be defined using videofluoroscopic swallowing study findings. Participants will be classified as improved if they show improvement in Penetration-Aspiration Scale score and/or reduced pharyngeal residue at Week 5 compared with baseline. The primary comparison will be between the immediate intervention group and the delayed-intervention group at Week 5, before the delayed-intervention group begins the exercise program.
Time frame
Baseline to Week 5Secondary outcomes
1
Proportion of Participants With Improved Swallowing Function or Physiology at Week 10
Participants will be classified as improved if they show one or both of the following at Week 10 compared with baseline: shorter time to laryngeal vestibule closure in association with improvement in Penetration-Aspiration Scale score; and/or improved pharyngeal constriction in association with reduced pharyngeal residue. Pharyngeal constriction and residue will be measured from videofluoroscopy using pixel-based tracing normalized to cervical spine length.
Time frame
Baseline to Week 102
Change in Munich Dysphagia Test-Parkinson Disease Score
Participant-reported swallowing symptoms will be measured using the Munich Dysphagia Test-Parkinson Disease questionnaire. Lower overall scores indicate improvement. Change from baseline will be assessed at Week 5, Week 10, 6 months, and 12 months.
Time frame
Baseline to Week 5, Week 10, 6 months, and 12 monthsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: